Hardenable orthopaedic supports

ABSTRACT

The present invention provides improved hardenable orthopaedic supports and methods of making the same. One embodiment provides a support which includes a blank made of a permeable, flexible material and including a structural region impregnated with a hardenable material and a peripheral region which will remain flexible after the hardenable material is hardened. Another embodiment provides a method of manufacturing an orthopaedic support in which a permeable, flexible material is positioned adjacent a recess of a molding element; the flexible material is contacted with a hardenable material; and the hardenable material is placed under pressure in the molding element to impregnate the section of the flexible material with the hardenable material.

CROSS-REFERENCE TO RELATED APPLICATION(S)

[0001] This patent application claims priority to, and is acontinuation-in-part of, U.S. patent application Ser. No. 09/823,968,filed Mar. 29, 2001, incorporated herein by reference in its entirety.

TECHNICAL FIELD

[0002] This invention relates to improved hardenable orthopedicsupports, e.g., splints or casts.

BACKGROUND

[0003] Orthopaedic supports are used to provide structural supportand/or limit movement of a portion of a patient's anatomy. Hardenablesplints and casts are commonly formed by wrapping or otherwisepositioning layers of a strip or “tape” of hardenable material about theafflicted area and allowing the material to harden in place. Gauzecoated with calcined gypsum has been used for many years, but moremodern hardenable supports are formed with other fabrics, e.g., knittedfiberglass, and employ hardenable organic resins instead of calcinedgypsum. For example, U.S. Pat. No. 4,996,979, granted Mar. 5, 1991, andU.S. Pat. No. 4,683,877, granted Aug. 4, 1987 disclose water-hardenableorganic resins used in this context. Other hardenable resins used inthis field include epoxies and UV-curable materials.

[0004] When using such tapes in forming orthopaedic supports, multiplelayers of the tape are wrapped about or positioned on the limb or otheraffected part of the patient's anatomy. In applying the tape to form acast, for example, care must be taken to firmly engage the layers duringthe exotherm portion of the setting period to ensure unitary bonding ofthe entire layered cast or assembly. This step requires care andexpertise to ensure that the layers are properly bonded without causingpain or discomfort to the patient, e.g., when forming a cast around abroken limb. Applying fiberglass tape to form a water-hardenable core ofa splint or support requires considerable skill and practice to formsplints or supports of varying thickness which may be required or whichmay be desirable for certain applications. Thus, for example, when acast is to be provided for a foot and lower leg, it may be desirable tohave greater thickness in the lower portion of the cast, and a lesserthickness in the vicinity of the shin or the calf of the user. Applyinglayers of fiberglass cloth requires considerable experience to form avarying thickness layered cast or support which will have properinter-layer bonding and strength.

[0005] Not all hardenable orthopaedic supports are formed by winding anelongate strip of tape around the limb or other anatomical structure.For example, U.S. Pat. No. 6,186,966, granted Feb. 13, 2001 and entitled“Hardenable Orthopaedic Support With Improved Configuration”, suggests asupport which, in one configuration, may be pre-shaped to be reliablyplaced on an anatomical structure, e.g., a palm, wrist and forearm.Certain embodiments include a pair of spaced interwoven layers formed ofhigh-strength materials with an open matrix of filaments or threadsinterconnecting the layers. The support is flexible and can conform tothe intended anatomical structure without forming wrinkles, which lendthe product an unsightly appearance and can lead to patient discomfort.This approach also avoids the necessity to wrap plural layers of tape,contour the tape to appropriately fit the limb, and compress the layerstogether to avoid delamination.

[0006] Another problem encountered in this field is the fraying of theedges of material when fabric, such as fiberglass fabric, is cut. Whenthe hardenable resin cures, the frayed edges may harden and may causepatient discomfort or abrade adjacent soft tissue. This difficulty oftenplagues orthopaedic supports, including pre-shaped hardenable supports.Typically, the material which carries the resin is coated in acontinuous process, e.g., by spraying or dipping the material in a bathof the resin and squeezing out some of the excess resin between a pairof rollers. Many commercially available hardenable resins, e.g.,urethane resins, are viscous, tacky fluids which may stick to a die orother cutting equipment, making it very difficult to cut desired shapes.As a consequence, most commercially successful hardenable orthopaedicsupports to date are sold in the form of continuous tape or rectangularswatches of a predetermined size, which must then be arranged on thepatient's limb.

[0007] Some hardenable orthopaedic supports employ an inner structurewhich carries the hardenable resin and one or more external layers. Forexample, one of the splint structures suggested in U.S. Pat. No.6,186,966, noted above, includes a water-pervious outer layer and aninner layer adapted to keep the patient's skin dry. Water-hardenableorthopaedic supports are often stored and shipped in sealed,water-impervious packages, e.g., a plastic blister pack. The resin is incontact with the our layers during storage and shipment and, over time,resin can migrate through one or both of the outer layers. When thisproduct is removed from the package, wetted (if necessary) and appliedto the patient, the resin on the outside of the product can harden onthe physician's or technician's hands and can harden on the patient'sskin. This can also lead to an irregular, mottled surface, making thesupport less attractive and lending a less professional appearance.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] FIGS. 1A-D are plan, left, top, and bottom views, respectively,of an orthopaedic support for use in a splint or cast for an extremityof a patient in accordance with an embodiment of the invention.

[0009] FIGS. 2-9 show alternative embodiments of orthopaedic supportsfor use in splints or casts for patients' extremities.

[0010]FIG. 10 is a cross-sectional view of the orthopaedic support ofFIG. 1 taken along line 1-1 of FIG. 1A.

[0011]FIG. 11 is a cross-sectional view of a double-knit type materialwhich may be employed in the fabrication of an orthopaedic support inone embodiment.

[0012]FIG. 12 is a cross-sectional view of central layer of double-knittype material reinforced by layers of high strength material which maybe employed in the fabrication of an orthopaedic support in one anotherembodiment.

[0013]FIG. 13 is an exploded perspective view of an orthopaedic supportin one alternative embodiment.

[0014]FIG. 14 is a top plan view of a complementary pair of moldingmembers useful in manufacturing the hardenable orthopaedic support ofFIGS. 1 and 10.

[0015]FIG. 15 is a schematic partial cross-sectional view of the moldingmembers illustrated in FIG. 14 juxtaposed with a subassembly of ahardenable orthopaedic support positioned herein.

DETAILED DESCRIPTION

[0016] Various embodiments of the present invention provide orthopaedicsupports, subassemblies for such supports, methods of manufacturingorthopaedic supports, and apparatus for use in manufacturing orthopaedicsupports. The following description provides specific details of certainembodiments of the invention illustrated in the drawings to provide athorough understanding of those embodiments. It should be recognized,however, that the present invention can be reflected in additionalembodiments and the invention may be practiced without some of thedetails in the following description. To facilitate understanding andreadability, a few select shapes will be discussed, followed by a moredetailed analysis of the internal structure of certain embodiments, andmethods in accordance with other embodiments are then described.

[0017] In one embodiment, a hardenable orthopaedic support for providingorthopaedic care to a patient is disclosed. In this embodiment, thesupport comprises a layer of padding material having an outer portion, alayer of napped material, and a blank made of a flexible, permeablematerial. The layer of napped material may have a substantially smoothside, a napped side, and an outer edge portion, where the napped sidefaces the blank. The outer portions of the layers of napped material andpadding material may be at least partially attached. The blank may be atleast partially impregnated with a hardenable material, and the blankmay be located between the layer of napped material and the layer ofpadding material.

[0018] In another embodiment, a method of using a hardenable orthopaedicsupport is disclosed. In this embodiment, the method comprises forming ablank, the blank being at least partially permeable to an activatingagent and impregnating at least part of the blank with a hardenablematerial which will harden in response to application of the activatingagent. The method may also comprise enclosing the blank between twolayers of material, wherein at least one of the materials is a nappedmaterial, wherein the napped material has a napped side facing theblank. The method may also comprise connecting the two layerssubstantially near their edges to completely enclose the blank and forma support structure.

[0019] EXEMPLARY DESIGNS

[0020] FIGS. 1A-D show an orthopaedic support 10 in accordance with oneembodiment for providing splinting or casting action for an extremity ofa patient. The orthopaedic support 10 shown in FIG. 1 is particularlywell-adapted for use with an upper extremity, such as a patient's arm,and includes three laterally-extending lobes 12 a-c separated by twonarrowed joining regions 14 a-b. In this particular embodiment, thelobes 12 and joining regions 14 are generally symmetrical about alongitudinally-extending axis A. In the illustrated embodiment, each ofthe lobes 12 have a width (measured transversely at its widest point) atleast about 1.3 times the width (measured transversely at its narrowestpoint) of the or each contiguous joining region 14. In one embodiment,each of the lobes 12 has a width at least about 1.5 times the width ofat least one contiguous joining region 14. In the support 10 of FIG. 1,the distal joining region 14 a has a first width W₁, the proximaljoining region 14 b has a second width W₂, and middle lobe 12 b has athird width W₃. The third width W₃ is at least about 1.3 times both thefirst width W₁ and the second width W₂ and is at least about 1.5 timesthe first width W₁.

[0021] The orthopaedic support 10 is designed to drape over a patient'slimb and to minimize wrinkles in the final cast or splint, as wrinklescan cause pressure points and ultimately cause discomfort or injury tothe patient. The support 10 also guides a medical professional inplacing the support 10 on a patient, as each lobe 12 and joining region14 corresponds to a particular part of a patient's anatomy. For example,the distal lobe 12 a may extend about a portion of the patient's handdistal of the thumb; the distal joining region 14 a may be aligned withthe thumb to position the thumb and its web space between the distal andmiddle lobes 12 a-b of the support 10; the middle lobe 12 b may extendbetween the thumb and the wrist; the proximal joining region 14 b may bealigned with the wrist to comfortably receive the ulnar styloid; and theproximal lobe 12 c may extend proximally to at least partially encirclea length of the forearm.

[0022] In addition to facilitating positioning of the support 10 at theproper general location, the design shown in FIG. 1 enables articulationof the support 10 to better conform to each patient's anatomy. Morespecifically, the narrower joining regions 14 can accommodate morelateral torsion, e.g., bending of the axis A in FIG. 1A into anon-linear shape to better accommodate a patient's anatomy. In thisregard, the shape of the support 10 can be flexed and contoured to meetthe needs of each patient, unlike more conventional rectangularsupports. The multi-lobed design of orthopaedic support 10 can also bebeneficial in that the lobes may be sized to ‘grab’ more of a patient,and thus keep the support more stable, without causing the patient unduediscomfort.

[0023] As explained in more detail below, the orthopaedic support 10 maybe formed of a flexible and/or stretchable material, e.g., animpregnated, hardenable double-knit material as described in relation toFIGS. 10-13, to permit the support 10 to readily drape over a patient'slimb. This draping ability and the multiple-lobed shape of the support10 can reduce the likelihood of developing wrinkles in the final,hardened cast or splint. Unless great care and expertise is used inapplying conventional tape-type splints, such splints can wrinkle fairlyreadily, creating pressure points that may cause the patient discomfortor injury.

[0024] Once properly positioned, the orthopaedic support 10 may be heldin place by a temporary aide such as an elastic bandage, a hook-and-looptape (e.g., VELCRO® tape), gauze, a bias stockinette, or any othersuitable means. The natural draping effect of the support 10 can alsohelp stabilize the support while wrapping the elastic bandage orapplying any other temporary aide. The orthopaedic support 10 can beused alone or, as discussed below, may be used as a subassembly of amore complex support (e.g., support 15 of FIG. 12, which employs thedevice of FIG. 1 as a blank 10 within an envelope 50 having beneficialproperties for some applications).

[0025] FIGS. 2-9 show several different orthopaedic supports inaccordance with alternative embodiments. The orthopaedic supports100-170 depicted in FIGS. 2-9 may be formed of similar materials and insimilar methods to those outlined below, and may function similarly tothe orthopaedic support 10 shown in FIG. 1 and described above. Thesealternative supports 100-170, however, are shaped differently from thesupport 10 of FIG. 1.

[0026] The orthopaedic support 100 of FIG. 2 has a pair of lobes 102 a-bseparated by a single narrow joining region 104. Such a 2-lobed designmay be used to support an arm, but it may be more appropriate for otheranatomical structures, e.g., a leg. Both of the lobes 102 a-b have awidth which is at least about 1.5 times the width of the joining region104; in the particular illustrated shape, the distal lobe 102 a has awidth at least about 1.75 times the width of the joining region 104 andthe proximal lobe 102 b has a width at least about 2.5 times the widthof the joining region 104.

[0027] The orthopaedic support 110 of FIG. 3 has a pair of lobes 112a-b, a distal narrow length 114 a which extends distally of the distallobe 112 a, and a narrow joining region 114 b between the distal lobe112 a and the proximal lobe 112 b. The orthopaedic support 120 of FIG. 4has an elongate joining region 124 between a distal lobe 122 a and aproximal lobe 122 b. The joining region 124 in this embodiment has aproximal length 124 b of substantially constant width and a narrowedneck 124 a connecting the proximal length 124 b to the distal lobe 122a. FIG. 5 illustrates an orthopaedic support 130 having a distal lobe132 a and a proximal lobe 132 b separated by a narrow joining region 134a and a proximal length 134 b which extends proximally from, and isnarrower than, the proximal lobe 132 b. In FIG. 6, orthopaedic support140 includes a distal lobe 142 a and an elongate proximal lobe 142 b,which may be generally rectangular in shape or may taper outwardly in aproximal direction. A narrow joining region 144 may connect the twolobes 142.

[0028] Unlike the multi-lobed designs of FIGS. 1-6, the orthopaedicsupport 150 of FIG. 7 has a single wide proximal region 152, which mayflare out proximally, and a generally rectangular distal region 154,which is narrower than the proximal region 152. Although this shape doeshave utility, it is not considered to be as beneficial as some of thepreviously-described embodiments, e.g., the support 10 of FIG. 1. FIG. 8illustrates a design which has a distal length 162 with alaterally-extending tongue 163, a distal joining region 164 a, a distalflared region 166 a, a proximal joining region 164 b, and a proximalflared region 166 b. The orthopaedic support 170 of FIG. 9 has a distallength 172 with a laterally extending tongue 173, a narrow joiningregion 174, and an elongate proximal region. The asymmetrical designs ofFIGS. 8 and 9 can be advantageous in some applications, but may not beas widely useful as the symmetrical design shown in FIG. 1, for example.

[0029] EXEMPLARY STRUCTURES

[0030] Referring back to FIG. 1, the orthopedic support 10 may include acentrally-disposed structural region 20 and a peripheral region 22extending outwardly beyond the structural region. In the illustratedembodiment, the peripheral region 22 extends about the entire peripheryof the structural region 20 and has a substantially constant width aboutthe entire periphery. As a consequence, the structural region 20 has thesame general multi-lobed, nonrectangular shape as the entire support 10.In other embodiments, the peripheral region 22 extends around only aportion of the circumference of the structural region 20, with thestructural region 20 extending to the edge of the support 10 along theremainder of its circumference. The width of the peripheral region 22may be varied as desired. It is anticipated that a peripheral region 22having a width of about ⅛ inch to about ½ inch, e.g., about ⅛ inch toabout ¼ inch, will suffice for most applications.

[0031] Some or all of the support 10 may be impregnated with ahardenable material. The hardenable material is adapted to harden inresponse to a specific activating agent. For example, a water-hardenablematerial, such as a prepolymerized urethane material, may be employed.When the water-hardenable material contacts water, it will harden.Water-hardenable materials are well known, and have been used heretoforein orthopaedic devices. See, for example, U.S. Pat. Nos. 4,996,979 and4,683,877, both of which are incorporated herein in their entirety. Asis known in the field, other hardenable materials may instead be used,such as UV-curable resins or one component of a two-component epoxy.

[0032] In one embodiment, the structural region 20 of the support 10 isimpregnated with the hardenable material, but the peripheral region mayremain free of the hardenable material. As a consequence, when thesupport 10 is in place and the water or other agent is used to activatethe hardenable material, the structural region will harden to supportthe limb or other anatomy to which it is applied. Because the peripheralregion 22 is free of the hardenable material, the peripheral region willnot harden when contacted with water. As a consequence, the peripheralregion may flex with the patient's movements, both increasing patientcomfort and avoiding abrasion or other damage which can occur with thestiff projecting edges of conventional casting tapes or the like.

[0033] A variety of cross-sectional structures may be suitable for theorthopaedic support 10 of FIG. 1. FIG. 10 is a schematic cross-sectionalview of the orthopaedic support 10 in one such embodiment taken alongline 10-10 of FIG. 1. As shown in FIG. 10, the support 10 may comprise adouble-knit fabric 32 including surface knits 34 and 36 and spacer yarns38. The surface knits 34 and 36 can be of the same or different knitpatterns. These patterns can range anywhere from smooth, essentiallycontinuous surfaces to meshes and other more complex knits. They may beknit from materials such as polyester, nylon, and various high strengthfibers, including fiberglass, aramid and/or carbon fibers. The spaceryarns 38 keep the surface knits 34 and 36 a specific distance apart, andallow for individual surface movement. The spacer yarns 38 may comprisemonofilament yarns, but can also be multi-filament yarns. The spaceryarns 38 may be made from polyester, nylon, or other thermoplasticmaterials that can be drawn into a yarn of the desired diameter; theymay also be made from glass or aramid fibers. The thickness of thedouble-knit-type material may range from about {fraction (1/16)}-inchthickness to about ¾-inch thickness, with about ⅛-inch to about ⅜-inchbeing preferred. In another embodiment (not shown), a permeable foammaterial may be used instead of the spacer yarns, with the surface knits34 and 36 being formed as separate knit layers and subsequently bondedto opposite faces of the foam, e.g., with an adhesive.

[0034] In one embodiment, the double-knit type material includes asubstantial proportion of high strength materials such as fiberglass,aramid fibers such as KEVLAR, or carbon fibers. It is noted thatfiberglass, KEVLAR, and carbon fibers may all have tensile strengthswhich are an order of magnitude or more greater than the tensilestrength of many thermoplastics, e.g., LDPE. More generally,high-strength fibers used in certain embodiments have tensile strengthsgreater than 500 MPa, e.g., 1,000 Mpa or greater. They also may befairly stiff. To better accommodate this stiffness, the double-knit typefabric may be of a fairly loose weave.

[0035] In one suitable double-knit fabric, the upper layer 34 and thelower layer 36 are formed of fiberglass and the open matrix ofinterconnecting fibers 38 is formed of 30 denier polyester monofilament,a thermoplastic material. The fiberglass constitutes about 71% by weight(wt. %) of the assembly, and the polyester comprises the remaining 29wt. %. Using this type of assembly, with a relatively stiff,high-strength material and a thermoplastic material, the double-knittype fabric may be concurrently cut and heated to melt and fuse thethermoplastic into the fiberglass, thereby limiting fraying orunraveling of the cut edges. Ultrasonic cutting and sealing equipment toaccomplish the foregoing is available, for example, from BransonUltrasonics Corp., 41 Eagle Road, Danbury, Conn. 068131961. Moregenerally, the amount of the fiberglass or other stiffer, high-strengthfilaments may range from 10 wt. % to 100 wt. % of the double-knitfabric, e.g., about 20 wt. % to 80 wt. %, with the remainder comprisingany desired filaments to suit the application, with a thermoplasticbetter enabling the cut edge treatment described above.

[0036]FIG. 11 schematically illustrates a modified embodiment of asupport 10 a that reinforces the double-knit fabric with glass knits orother high strength fabrics to increase their strength. In thisparticular embodiment, fiberglass fabric 40 and 42 may be bonded to thesurface knits 34 and 36 by adhesive webs 44 and 46, respectively. Thisbonding could also be achieved by any other known technique such as byflame bonding, or by sewing, for specific examples. The lamination ofthe glass knit fabrics 40 and 42 to the double-knit material by theadhesive layers 44 and 46 also reduces fraying of the glass knit whenthe assembly is cut, and can help hold the entire assembly intact duringsubsequent operations.

[0037] If so desired, the support 10 shown in FIG. 1 may be employed asa casting blank which is retained in an outer envelope. FIG. 12illustrates an orthopaedic support 15 in accordance with one suchembodiment. The support 15 includes a blank, illustrated as the support10 of FIGS. 1 and 10, positioned in a flexible envelope 50. If sodesired, the blank may have any other suitable structure. For example,the blank or central body material may comprise a reinforced double-knitmaterial 10 a as described in relation to FIG. 11, multiple layers ofdouble-knit material, multiple layers of double-knit material separatedby a foam laminate or other divider, foam material with a single-knitmaterial attached to both sides (such as cast tape), a layer of foamwithout any fabric attached thereto, multiple layers of single-knitmaterial. Instead of knit materials, woven materials, felted materials,or other nonwoven materials may be employed. In one particularembodiment, the blank 10 of FIG. 12 comprises a layer of a flexible,water-permeable foam material with at least a central support region ofthe foam being impregnated with a water-hardenable material.

[0038] The orthopaedic support 15 of FIG. 12 includes an exterior layer60 and a interior layer 52 that together form an envelope 50 which maysubstantially encapsulate the blank 10. The exterior layer 60 isdesigned to be on the outside of the orthopaedic support 15 whenapplied, while the interior layer 52 is designed to be adjacent thepatient's skin (and possibly separated by a fabric, bandage or otheritem). In one embodiment, the exterior layer 60 is made of a materialhaving a relatively smooth external surface 62 and a lofty, internal nap64. In certain embodiments, the exterior layer 60 comprises theloop-type material or hook material of a mating hook and loop-typefastening system, such as VELCRO®. In one suitable embodiment theexterior layer comprises an unbroken loop material (“UBL”), which maycorrespond to the “soft,” “fuzzy” loop-type material of a mating hookand loop-type fastener. In one particular embodiment, the UBL comprisesa flexible knit fabric which has one napped surface. The exterior layer60 may be placed with the napped side 64 facing the blank 10 and thesmoother backing 62 facing outwards. The exterior layer 60 may also beformed of any other napped material, e.g., a knitted material such asterrycloth. In this embodiment, the napped side of the material would beplaced facing the blank 10. In another alternative embodiment, anysuitably flexible and/or stretchable material with a high loft may beused, typically with a high loft side facing the blank 10. Nappedmaterials, including unbroken loop materials, are available from sourcessuch as Gehring Textiles Inc. of New York, N.Y.

[0039] The interior layer 52 may be made of foam padding, e.g., anopen-cell polyurethane. Foam padding may provide comfort for thepatient, as the interior layer 52 will likely be the layer touching thepatient's anatomy. One skilled in the art will recognize that theinterior layer 52 may be made of a wide variety of materials, such asfabric, UBL materials, napped materials, other padding, etc.

[0040] The exterior layer 60 and interior layer 52 may be bondedtogether at their outer edges 54, 66 by thermal welding, by permanentadhesive, by ultrasonic welding, stitching, or in any other desiredmanner. The bonding may be accomplished in successive spots or lines ormay be continuous. The impregnated blank 10 is therefore containedwithin the envelope 50 between the exterior layer 60 and interior layer52, which will inhibit migration or leaking of the resin during shipmentand storage. In one embodiment, the blank 10 is placed between theexterior layer 60 and interior layer 52 immediately after beingimpregnated. Once the exterior layer 60 and interior layer 52 are bondedtogether, the orthopaedic support 15 may be sealed in a watervapor-impermeable package (not shown). Sealing the orthopaedic support15 in the package quickly can reduce exposure to moisture contained inthe air. If a UV-curable resin or the like is instead used to harden thesupport 10 once in place, the package need not be watervapor-impermeable, but it should be opaque to ultraviolet radiation.

[0041] The water vapor-impermeable package may be formed of metallizedmylar, aluminum foil, or any known water vapor-impermeable materialwhich will reduce the chances of premature activation and hardening ofthe urethane or other water-hardenable material which is impregnatedinto the blank 10. One suitable water vapor-impermeable sheet materialcomprises aluminum foil coated with plastic on both sides, availablefrom Richmond Tech, Inc., 1897 Colton Avenue, Redlands, Calif.92374-9797. This material has a low moisture vapor transfer rate ofabout 0.0006 grams per 100 square inches per day.

[0042] In one embodiment, the blank material is initially impregnatedwith the water-hardenable material, and then the entire soft goodproduct, tape or blank, is packaged in a water vapor impermeablepackage. When it is time to apply the product to a patient, the packageis opened, the product is immersed in water or water is applied to it,and the product is mounted onto the part of the anatomy requiringsupport or splinting. With the open-work matrix of the double-knitmaterial, for example, rapid and thorough penetration of the water andactivation of the urethane occurs. In the case of soft goods types ofproducts, straps may be employed to mount the support firmly on theinjured portion of the anatomy, water is applied or injected, and thewater-hardenable material conforms to the configuration of the patient.In another embodiment, blanks may be immersed in water and promptlyapplied to the injured portion of the anatomy before the hardeningoccurs.

[0043] The use of a napped material prevents or slows down resin (orother hardenable material) migration over time. This effect appears tobe stronger when the napped side of a napped material such as UBL islocated adjacent a resin-impregnated material. As noted above, resin hasa tendency to leak or migrate out of an orthopaedic support over time,such as during shipping or storage. When the orthopaedic support isultimately activated, the resin that has leaked out may causeimperfections or protuberances on the outer surface of an orthopaedicsupport. It has been found that UBL is useful in preventing or retardingresin migration, even during long shipping or storage periods. By usinga napped material such as UBL as an exterior layer 60, the orthopaedicsupport 15 of FIG. 12 also provides a smoother and cleaner outer surfaceon the finished support because of the smooth surface of the backing 62of the napped material and the reduced migration of hardenable materialtherethrough.

[0044] The UBL material used in selected embodiments provides a smoothexternal surface with minimal wrinkles. The relatively smooth surface isinherent with many UBL materials, and the ability of UBL materials tostretch and flex reduces the number of unsightly wrinkles on theorthopaedic support 15. In addition, UBL materials are generallyquick-drying, so that when the orthopaedic support 15 is, for example,immersed in water to activate the resin, the UBL material 60 (and thusthe outside of the support 15) dries quickly. UBL materials are alsorelatively light and strong when compared to alternative materials, andare also more resistant to damage, such as scratches or tears. This isparticularly true when compared to foam padding. UBL materials may alsobe lower profile than foam padding, which tends to be somewhat bulky.

[0045] In one embodiment, UBL or napped materials with a larger amountof loft may be used. Loft is the thickness of the “fuzzy” or napped partof the unbroken loop material. It is believed that a thicker loft mayresult in additional resistance to flow or migration of resin. This maybe related to the fact that loft creates a layer of air between thefabric and the blank 10; it is believed that this layer of air limitscontact between the resin and the outer body of the napped fabric,limiting migration of resin or other hardenable material through thethickness of the fabric to the exterior surface.

[0046] As described above, the interior layer 52 may be made of foampadding or other padding in one embodiment. Foam padding, like UBLmaterial, provides resistance to flow or migration of resin; closed-cellfoams may be better in this regard than open-cell foams. Foam padding,however, is not optimal for use on the exterior layer 60, as it iseasily scratched or damaged. Foam padding does provide a satisfactorylevel of cushioning for the patient, making the orthopaedic support 15more comfortable. In one embodiment, the foam padding is betweenone-eighth (⅛″) of an inch and five-eighths of an inch (⅝″) thick. Oneskilled in the art will recognize that many alternatives for both theinterior layer 52 and exterior layer 60 exist, such as using a UBLmaterial for an interior layer 52, using foam padding as an exteriorlayer 60, having both layers made of the same material, using fabrics,plastic sheeting, or other materials for either layer. Suitable foamsare commercially available from a number of sources, including FoamexInternational of Linwood, Pa.

[0047] In one embodiment, the orthopaedic support 15 (and thus theinterior layer 52, exterior layer 60, and blank 10) has substantiallythe same shape as the blank 10 described in relation to FIG. 1. In thisembodiment, the interior layer 52 and exterior layer 60 may be slightlylarger than the blank 10 so the layers can be sealed together at theiredges 54 and 66 to create the envelope 50 of the orthopaedic support 15.One skilled in the art will recognize that other shapes, such as thosedescribed in relation to FIGS. 2-9, are also suitable and within thescope of the invention. In another embodiment, the envelope 50 of thesupport 15 has a shape which is different from the shape of the blank10.

[0048]FIG. 13 is an exploded perspective view of the orthopaedic support15 of FIG. 12. In FIG. 13, the interior layer 52 and the exterior layer60 form the outer envelope (50 in FIG. 12) of the orthopaedic support15. The slightly smaller blank 10 fits within the inner and outer layers52, 60. If so desired, a reinforcement 70 may be included to provideadditional stiffness and/or strength to the orthopaedic support 15. Thereinforcement 70 may be attached to the blank 10 (such as by anadhesive, etc.) or may otherwise be located within or on the externalsurface of the envelope 50 of the orthopaedic support 15. In thisembodiment, a reinforcement 70 impregnated with a hardenable material isused. This reinforcement 70 provides additional stiffness when theorthopaedic support 15 is hardened for use. The reinforcement 70 canalso provide additional high strength fibers, such as fiberglass, to theorthopaedic support 15, which also adds strength and stiffness to thesupport 15. In one embodiment, the reinforcement 70 may comprise one ormore layers of single knit glass and have a rectangular shape, thoughother shapes may instead be employed. In another embodiment, thereinforcement 70 may comprise an impregnated casting tape having acentral area of double-knit type fabric, an exterior layer, an interiorlayer, and an intermediate open-work matrix of yarns or fibersintegrally knit or woven into the fabric and extending between the twolayers, where at the edges of the tape the two layers are merged into asingle thickness of fabric. One skilled in the art will recognize thatmany other materials, shapes, and designs may be used for areinforcement 70 and all are within the scope of the invention.

[0049] In one embodiment, the reinforcement 70 extends longitudinallyalong at least a portion of the structural region (20 in FIGS. 1 and 12,for example), but does not extend into the peripheral region 22. If twoor more narrowed joining regions (14 in FIG. 1, for example) are used,the reinforcement may extend longitudinally through all of the joiningregions. Looking at FIG. 1A, the reinforcement 70 (not shown in FIG. 1A)may extend proximally along the axis A from a distal end in the distallobe 12 a to a proximal end in the proximal lobe 12 c. For example, arectangular three-inch (3″) wide strip of impregnated tape could beused, as well as other shapes and sizes. This additional reinforcement70 enables the use or narrower joining regions 14 without undulysacrificing strength and stiffness of the finished article.

[0050] In the illustrated embodiment, the reinforcement 70 is anelongate rectangle. Other suitable shapes may instead be employed. If sodesired, the reinforcement 70 has a non-rectangular shape. In oneembodiment (not shown), the reinforcement 70 has a multiple-lobed designgenerally corresponding to the arrangement of the blank, with a widerlobe being positioned in one or more of the lobes 12 of the blank and anarrower section being received in one or more of the joining regions14. It is anticipated that the reinforcement 70 in such an embodimentwill be smaller than the blank, though, with the periphery being spaceda fixed or variable distance from the peripheral region 22 of the blank10.

[0051] The reinforcement 70 may be held in place with an adhesive orother attachment, or may also be held in place by the covering materials(e.g., the exterior layer 60). In one embodiment, the reinforcement 70will bond with the blank 10 as the hardenable material hardens and thetwo items laminate together, which will also help prevent relativemovement between the reinforcement 70 and the blank 10, furtherstrengthening the hardened support.

[0052] EXEMPLARY METHODS OF MANUFACTURE

[0053] Orthopaedic supports in accordance with embodiments of theinvention may be manufactured in a variety of ways. For ease ofunderstanding, reference is made in the following discussion to thespecific support or blank 10 and support 15 shown in FIGS. 1 and 10-13.It should be recognized, however, that aspects of the present inventioncan be used to manufacture blanks or supports having other shapes andstructures, as well.

[0054] In one embodiment, a suitable hardenable material is applied tothe material from which the support or blank 10 is formed and thismaterial is then cut to the desired non-rectangular shape. If sodesired, this cut blank 10 may be used as a support without anyadditional layers. Alternatively, the blank 10 can be received within anenvelope 50 and this assembly can be used as a support 15.

[0055] As noted above, though, many of the hardenable materials used inorthopaedic applications are tacky, viscous materials which are notconducive to cutting one blank 10 after another in a commercialproduction environment. Cutting the desired shapes from continuouslycoated material essentially necessitates that the entire blank 10 carrythe hardenable material and producing a peripheral region which is freefrom the hardenable material, if such a peripheral region is desired,would be problematic.

[0056] In a method in accordance with another embodiment of theinvention, the hardenable material is urged under pressure in a moldingelement to impregnate at least a portion of the flexible material fromwhich the support or blank is formed. This permits relatively complexshapes to be formed from fabric which has not yet been treated with thehardenable material. These shapes may be subsequently impregnated withthe hardenable material using the molding element. Alternatively, anexcess of the flexible material used to form the support 10 may beplaced in the molding element. Only the shape corresponding to a moldshape of the molding element will be impregnated with the hardenablematerial. Thereafter, excess fabric can be trimmed, leaving animpregnated blank 10 of the desired shape. In this application, theentire blank 10 may be impregnated with the hardenable material.

[0057] In an alternative embodiment, a blank 10 is produced with astructural region 20 impregnated with hardenable material and aperipheral region 22 which is free from the hardenable material. FIG. 14illustrates a molding element 200 which is well-suited for manufacturingsuch blanks 10 on a commercial scale. The molding element 200 includes afirst molding member 210 and a second molding member 250. Theillustrated first molding member 210 contains two identical recesses 212a-b which are offset 1800 in orientation from one another. Similarly,the illustrated second molding member 250 includes two identicalprojections 252 a-b which are offset 180° in orientation from oneanother. The projections 252 a and 252 b of the second molding member250 are adapted to be received in a complementary one of the recesses212 a and 212 b, respectively, in the first molding member 210. Thisenables two supports 10 to be produced in a single operation of themolding element 200. The molding element 200 is not limited to aparticular number of pairs of recesses 212 and projections 252, however;molding elements having one or more recess/projection pairs are equallywithin the scope to the invention. In one embodiment, both of themolding elements 210 and 250 are made out of aluminum, although othermaterials, e.g., stainless steel or other metals or suitable plasticmaterials such as HDPE, can be used.

[0058] The first molding member 210 has a first confronting face 214 inwhich the recesses 212 are formed and the second molding member 250 hasa second confronting face 254 from which the projections 252 extend. Therecesses 212 are adapted to receive a hardenable material, e.g., awater-hardenable or UV-curable resin, therein. Peripheral steps 220 aand 220 b extend about the peripheries of the recesses 212 a and 212 b,respectively. These peripheral steps 220 may extend about the entireperiphery of the associated recess 212. Alternatively, the peripheralsteps may extend about less than the entire recess periphery. Similarly,projection 252 a of the second molding member has a peripheral step 260a which extends about at least a portion of the projection periphery andprojection 252 b has a has a peripheral step 260 a which extends aboutat least a portion of the projection periphery.

[0059]FIG. 15 schematically illustrates the two molding members 210 and250 juxtaposed for use. Only one recess 212 a and complementaryprojection 252 a is shown; the other recess 212 b and projection 252 bmay have substantially the same shape and are omitted for ease ofillustration. As shown in FIG. 15, the peripheral step 220 of the firstmolding member 210 is recessed from the confronting surface 214 andsurrounds the perimeter of the recess 212 and is used to support theperipheral region 22 of a blank 10. The peripheral step 220 helps tocontain resin or other hardenable material in the recess 212 duringmanufacture, as described below. The outer edge of the step 220 isconnected to the confronting surface 214 by a substantiallyperpendicular sidewall 224. The sidewall 224 approximates the perimeterof the intended blank 10. The confronting face 214 may be generallyplanar and define one plane and the step 220 may be recessed from theconfronting face 214 so the step 220 is in a second plane parallel andspaced apart from the first plane. The recess 212 is recessed from thestep 220 so as to be in a third plane spaced apart from the first andsecond planes. The outer surface 214, step 220 and recess 212 are inrespective planes that may be substantially parallel to each other andbe connected by portions of the first molding member 210 substantiallyperpendicular to those planes.

[0060] The projection 252 projects away from the confronting face 254 ofthe second molding member 250. The peripheral step 260 of the secondmolding member 250 is spaced apart from the confronting face 254 and isjuxtaposed with the step 220 on the first molding member 210 inmanufacturing the blank 10. A forcing surface of the projection 252 isspaced apart from the step 260 and is even further separated from theconfronting face 254 than is the step 260. The confronting face 254,peripheral step 260, and forcing surface of the projection 252 may be inthree different planes substantially parallel to each other and beconnected by portions of the second molding member 250 substantiallyperpendicular to those planes. The surfaces 252, 254, and 260 of thesecond molding member 250 correspond in size and pitch to the surfaces212, 214 and 220, respectively, of the first molding member 210. Thesesurfaces may be substantially level when in use. In an alternativeembodiment, the second molding member 250 need not comprise a singlecontiguous body with a continuous confronting face 254 adapted toclosely juxtapose with the confronting face 214 of the first moldingmember 210. For example, the second molding member 250 may comprise twoseparate bodies, each of which has the size and shape of one of theprojections 252 of the illustrated embodiment. Such an independentmember 250 may be used in a manner analogous to a punch in a punch anddie operation.

[0061] In use, a flexible material to be impregnated may be positionedwith respect to one or both of the recesses 212 and/or one or both ofthe projections 252. If so desired, the flexible material may already becut to conform to the shape of the sidewall 224 of a single one of therecesses 212. Alternatively, the flexible material may extend outwardlybeyond the sidewall 224, e.g., it may take the form of a large rectanglelarge enough to completely cover one or both of the recesses 212. Whenthe confronting faces 214 and 254 of the first and second moldingmembers 210 and 250, respectively, are juxtaposed, the recessed step 220of each recess 212 will confront the raised step 260 of thecorresponding projection 252. A portion of the oversized sheet offlexible material is received between these steps 220 and 260. Thisportion of the material may be treated with a flexible adhesivematerial, such as a flexible synthetic cement, as set forth in copendingU.S. application Ser. No. 09/823,968, entitled “Cast Blank EdgeTreatment,” the entirety of which is incorporated herein by reference.Treating this portion of the fabric with a flexible adhesive or the likecan provide a guide for trimming excess fabric from the edges of theblank 10 and will help keep the cut edges from fraying or sheddingfibers. Because a flexible adhesive is used, this will not compromisethe goal of maintaining a flexible peripheral region 22 of the blank 10.

[0062] Before or after the flexible fabric is positioned with respect tothe molding members 210 and 250, a quantity of hardenable material,e.g., a waterhardenable resin, can be dispensed into each recess 212 ofthe first molding member. The quantity of resin placed in the reservoirmay be precisely measured to deliver just the amount of resin necessaryto suitably impregnate the structural region 20. Depending on the natureof the resin, it may be advantageous to heat the resin to reduce itsviscosity, e.g., by heating one or both of the molding members 210 and250. FIG. 15 schematically illustrates a heat source for each of themolding members 210 and 250 as electrical resistance heaters 225 and265, respectively, but any suitable heat source may be employed. Toimpregnate the resin into the spacer, the projections 252 of the secondmolding member 250 are brought into alignment with the correspondingrecesses 212 of the first molding member 210 and the first and secondmolding members 210 and 250 are urged toward one another. This squeezesthe resin between a projection 252 and the corresponding recess 212,impregnating the resin into the fabric. The resin need not be placedunder pressure by squeezing the two molding members together. In anotherembodiment (not shown), a flexible membrane may extend over the top ofthe peripheral step 220 and the recess 212 of the first molding member210 and be sealed against the confronting face 214. By drawing a vacuumon the recess 212, the membrane will be drawn toward the bottom of therecess, placing the resin under sufficient pressure to allow it toimpregnate the fabric.

[0063] In the illustrated molding element 200, the peripheral region 22of the fabric is received between the peripheral steps 220 and 260 andmay be squeezed therebetween when the molding members 210 and 250 areurged toward one another. This will limit the ingress of resin from therecess 212 into the peripheral region 22. If a flexible adhesive or thelike is applied to the peripheral region 22, as noted above, forcing themolding members 210 and 250 toward one another will also squeeze theflexible adhesive to drive it into the peripheral region of the fabric.In an alternative embodiment, the adhesive may be applied to theperipheral region 22 and allowed to cure before the and the fabric maybe trimmed to the desired blank size before the fabric is placed in themolding element 200. The presence of the flexible adhesive may furtherrestrict movement of hardenable resin from the recess 212 into theperipheral region 22 of the blank 10.

[0064] By way of example, in manufacturing an orthopedic support 10 fora patient's upper extremity, approximately 43 grams of resin, plus orminus 1 gram, may be used for each edge-treated and cut support 10. Theamount of resin may vary depending on the dimensions of the orthopaedicsupport 10, though. The molding members 210 and 250 and the resin arepreferably heated to between 140 to 160 degrees Fahrenheit, but othertemperature ranges are also within the scope of the invention. Theflexible fabric is placed into the recess 212 of the first moldingmember 210 and the structural region of the fabric is held adjacent to,or in contact with, the resin. The molding members 210 and 250 may beforced together by a machine applying a force of approximately 70 poundsper square inch (“psi”) for between 30 and 60 seconds. Other ranges ofpressure and time are within the scope of the invention. This forces alarge percentage of the resin into the structural region 20 of thefabric, which ultimately will provide it with its stiffness when it ishardened.

[0065] After the allotted time has passed, the molding members 210 and250 may be separated and the resin-impregnated blank 10 can be removedfrom the molding element 200, for example by a gloved hand. If the blank10 is to be used as a support, it may be packaged in water-impermeablepackaging. If the blank 10 is to be used in manufacturing a more complexstructure such as that of the support 15 of FIG. 12, the blank 10 may bepositioned between an inner layer 52 and an exterior layer 60 and thosetwo layers 52 and 60 may be bonded to one another to create the envelope50 within which the blank 10 is received.

[0066] It is to be understood that the foregoing detailed descriptionand the accompanying drawings relate to some of the potentialembodiments of the invention. Further modifications and variations ofthe present invention are contemplated. For example, with regard tomaterials which may be used, one or both of the outer layers of thedouble-knit-type material may be of high strength material, such asfiberglass, aramids such as kevlar, or other high strength fibers ormaterials. The spacer yarns, and one of the two outer layers may beformed of polypropylene, polyester, nylon, or a high-strength material,e.g., fiberglass or aramids such as kevlar. Other materials and yarnsmay also be used.

[0067] It is further noted that the properties of the double-knit-typeknit-type casting material may be changed as desired by (1) alteringfilament size of the surface yarns or spacer yarns, (2) changing thetype of surface knits, (3) changing the density of spacer yarns, (4)interweaving stretchable yarns such as lycra to increase conformabilityand recovery, and (5) selectively inlaying high strength fibers such ascarbon, kevlar or the like. It is also noted that flat or contouredcasting blanks may be knit in a completed form so that the steps ofcutting the material and securing against fraying may be avoided. Inaddition, hardenable material other than water-hardenable material maybe employed in combination with an appropriate activating agent, e.g.,ultraviolet radiation for UV-curable materials or a second component ofan epoxy or other known two-part polymer hardening systems. Concerningthe thickness of the double-knit type material, it may range from{fraction (1/32)} of an inch up to ½-inch or even one inch in thicknessdepending on the conformability and strength which is required ordesired.

[0068] Moreover, all of the disclosed embodiments may be of variablethickness to provide selected areas of increased strength or ofincreased conformity to bodily configurations. It is also noted that allof the embodiments of the invention may be provided with the moistureimpermeable packaging to avoid hardening of the supports or splintsprior to use, while in storage, on sale, or the like.

[0069] Unless the context clearly requires otherwise, throughout thedescription and the claims, the words “comprise,” “comprising,” and thelike are to be construed in an inclusive sense as opposed to anexclusive or exhaustive sense; that is to say, in a sense of “including,but not limited to.” Words using the singular or plural number alsoinclude the plural or singular number respectively. Additionally, thewords “herein,” “above,” “below,” and words of similar import, when usedin this application, shall refer to this application as a whole and notto any particular portions of this application. Use of the term “or,” asused in this application with respect to a list of two or more items,shall be interpreted to cover any, all, or any combination of items inthe list.

[0070] From the foregoing, it will be appreciated that specificembodiments of the invention have been described herein for purposes ofillustration, but that various modifications may be made withoutdeviating from the spirit and scope of the invention. Accordingly, theinvention is not limited except as by the appended claims.

[0071] Incorporated in their entirely by reference are the followingU.S. applications, which are assigned to the assignee of thisapplication: application no.______, entitled “Hardenable OrthopaedicSupports,” filed concurrently herewith and identified by Attorney DocketNo. 386798002US; and application no.______, entitled “HardenableOrthopaedic Supports,” filed concurrently herewith and identified byAttorney Docket No. 386798003US. Aspects of the invention can bemodified, if necessary, to employ the systems, functions and concepts ofthe various patents and applications described above to provide yetfurther embodiments of the invention.

[0072] The above detailed descriptions of embodiments of the inventionare not intended to be exhaustive or to limit the invention to theprecise form disclosed above. While specific embodiments of, andexamples for, the invention are described above for illustrativepurposes, various equivalent modifications are possible within the scopeof the invention, as those skilled in the relevant art will recognize.For example, while steps are presented in a given order, alternativeembodiments may perform routines having steps in a different order. Theteachings of the invention provided herein can be applied to otherdevices and/or systems, not necessarily the system described herein.These and other changes can be made to the invention in light of thedetailed description. The elements and acts of the various embodimentsdescribed above can be combined to provide further embodiments.

[0073] These and other changes can be made to the invention in light ofthe above detailed description. In general, the terms used in thefollowing claims, should not be construed to limit the invention to thespecific embodiments disclosed in the specification, unless the abovedetailed description explicitly defines such terms. Accordingly, theactual scope of the invention encompasses the disclosed embodiments andall equivalent ways of practicing or implementing the invention underthe claims.

[0074] While certain aspects of the invention are presented below incertain claim forms, the inventors contemplate the various aspects ofthe invention in any number of claim forms. Accordingly, the inventorsreserve the right to add additional claims after filing the applicationto pursue such additional claim forms for other aspects of theinvention.

I/We claim:
 1. A hardenable orthopaedic support comprising a blank madeof a permeable, flexible material and shaped to cover at least a portionof a patient's anatomy, the blank including a structural region and aperipheral region, the structural region of the blank being impregnatedwith a hardenable material, the peripheral region of the blank beingfree of the hardenable material and remaining flexible after thehardenable material in the structural region is hardened.
 2. Theorthopaedic support of claim 1 wherein the flexible material comprises afabric.
 3. The orthopaedic support of claim 1 wherein the flexiblematerial comprises a stretchable knit fabric.
 4. The orthopaedic supportof claim 1 wherein the structural region has a nonrectangular shape. 5.The orthopaedic support of claim 1 wherein the flexible materialcomprises a first fabric layer and a second fabric layer, centralregions of the first and second fabric layers defining the structuralregion of the blank and being impregnated with the hardenable material.6. The orthopaedic support of claim 1 wherein the flexible materialcomprises a first fabric layer and a second fabric layer, centralregions of the first and second fabric layers defining the structuralregion of the blank and being impregnated with the hardenable material,the blank further comprising a reinforcement layer carried by at leastone of the fabric layers and extending along a length of the structuralregion, the reinforcement layer having a width smaller than a width ofthe structural region.
 7. The orthopaedic support of claim 1 wherein theflexible material comprises a first fabric layer, a second fabric layer,and an internal core.
 8. The orthopaedic support of claim 7 wherein theinternal core comprises a foam.
 9. The orthopaedic support of claim 1wherein the flexible material comprises a first layer of knitted glass,a second layer of knitted glass, and an internal core coextensive withthe structural region of the blank.
 10. The orthopaedic support of claim1 further comprising a flexible envelope within which the blank isreceived and which is adapted to encase the blank when the hardenablematerial is hardened.
 11. The orthopaedic support of claim 1 furthercomprising a flexible envelope within which the blank is received, theenvelope comprising a fabric exterior layer and an interior layer, theexterior layer having a napped internal face oriented toward the blank.12. A method of manufacturing an orthopaedic support, comprising:positioning a permeable, flexible material with respect to a moldingelement, the material including a section shaped to cover at least aportion of a patient's anatomy, the flexible material being positionedadjacent a recess of the molding element; contacting the flexiblematerial with a quantity of a hardenable material; placing thehardenable material under pressure in the molding element to impregnatethe section of the flexible material with the hardenable material. 13.The method of claim 12 wherein the molding element comprises a firstmolding member and a second molding member, and the hardenable materialis placed under pressure by juxtaposing the first and second moldingmembers with the flexible material positioned between the first andsecond molding members.
 14. The method of claim 13 wherein the first andsecond molding members are forced toward one another to place thehardenable material under pressure.
 15. The method of claim 13 whereinat least one of the first and second molding members includes aperipheral step adapted to receive a peripheral region of the flexiblematerial, the peripheral step having a height less than a height of therecess of the molding element, the peripheral region of the flexiblematerial being positioned within the peripheral step.
 16. The method ofclaim 15 wherein the peripheral step extends around an entire peripheryof the recess, further comprising squeezing the peripheral region of theflexible material in the peripheral step when the hardenable material isplaced under pressure.
 17. The method of claim 12 further comprisingremoving the impregnated fabric from the molding element after placingthe hardenable material under pressure.
 18. The method of claim 17further comprising positioning the impregnated fabric between anexterior layer and an interior layer and joining the exterior layer andthe interior layer to define an envelope about the impregnated fabric.19. The method of claim 12 further comprising removing the impregnatedfabric from the molding element and placing the impregnated blank in aflexible envelope which is adapted to encase the blank when thehardenable material is hardened.
 20. The method of claim 12 wherein therecess has a non-rectangular shape to produce a blank having anon-rectangularly shaped structural region impregnated with thehardenable material.
 21. A method of manufacturing an orthopaedicsupport, comprising: positioning a flexible body with respect to amolding element, the body comprising a permeable, flexible material andhaving a nonrectangular shape adapted to conform to a specific portionof a patient's anatomy; contacting the flexible material with a quantityof a hardenable material; placing the hardenable material under pressurein the molding element to impregnate the flexible material with thehardenable material.
 22. The method of claim 21 wherein the body has astructural region and a peripheral region, the structural region beingimpregnated with the hardenable while the peripheral region remains freeof the hardenable material.
 23. The method of claim 21 whereincontacting the flexible material with a quantity of a hardenablematerial comprises delivering a measured quantity of the hardenablematerial to a surface of the molding element and bringing the fabricinto contact with the measured quantity of the hardenable material. 24.An apparatus for manufacturing an orthopaedic support, comprising: afirst molding member having a back and a confronting face; a secondmolding member having a back and a confronting face adapted to bejuxtaposed with the confronting face of the first molding member; and anirregular, non-rectangular recess formed in the confronting face of atleast one of the first and second molding members, the recess beingconfigured to receive a structural region of a flexible materialtherein, the structural region being sized and shaped to cover andsupport at least a portion of a patient's anatomy, an inner surface ofthe recess being formed of a material adapted to contact a hardenableresin.
 25. The apparatus of claim 24 further comprising a peripheralstep formed in the confronting face of at least one of the first andsecond molding members and extending around a periphery of the recess,the peripheral step having a height which is less than a height of therecess.